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As a backdrop to World Health Organization members meeting this week in search of a global strategy for future influenza pandemics, the pharmaceutical industry and other actors have been developing a keen interest in patents on influenza genetic resources. A sharp and sustained increase in patent activity on those materials was pointed out by a civil society group in a new report, which it says challenges a recent report by the World Intellectual Property Organization.

The “wave of intellectual property claims over pandemic influenza vaccines that began in 2006 continues unabated,” said the new report from Third World Network.

The Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits (OEWG PIP) is meeting in Geneva from 11-15 April, to finalise a framework to prepare for future pandemics. The group also met in December and a report [pdf] of their meeting was issued in January.

In the December working group report, the WHO director general was asked to “seek information from WIPO on Pandemic Influenza Preparedness (PIP)-related patents, including patent applications, in connection with the H5N1 virus and the pandemic (H1N1) 2009.”

On 1 April, WIPO issued a complex report on PIP-related patents and patent applications [pdf]. In its report, WIPO said that a “rigorous search” was carried out under the European Patent Office, the United States Patent and Trademark Office, and the Patent Cooperation Treaty (managed by WIPO), covering 142 countries. The search was made on a broad-based keyword of “H5N1” or “H1N1.”

The report confirmed the rise in patent applications, but made obvious technical distinctions between applications and actual granted patents, suggesting to trust the patent system to trim out applications that are not in the public interest. More particularly, the WIPO report characterised the applications in the positive light of having the potential to provide “more effective responses to an influenza pandemic than is the case with current vaccine manufacturing technologies which nevertheless are beneficial.” It then confirmed that it had not considered the impact on freedom to operate of the patent applications, meaning whether a flood of patents could interfere with the ability to innovate in future.

The WIPO report also contains disclaimers that it is only one approach among many possible ones.

Another possible approach was taken by Third World Network (TWN). In its report [pdf] issued on 8 April, it finds that proprietary rights on “influenza genetic sequences and the proteins they encode, used in vaccines,” get in the way of developing countries’ access to medicines.

The study, prepared by researcher Edward Hammond, shows a sharp rise in patent applications in this area since 2006, shortly after the outbreak of H5N1 in late 2005. Hammond looked at patent applications for influenza vaccines, applications for influenza vaccines including the terms “H5N1” and/or “H1N1,” and applications for medicines, vaccines, microbes, and some associated protein-like substances including the terms “H5N1” and/or “H1N1.”

Hammond’s methodology is based on the International Patent Classification and WIPO’s PatentScope database for patent applications. For example, in 2001, he found 19 PCT patent applications for influenza vaccines, and 63 applications in 2010. The main applicants come from the United States, followed by industrialised countries such as Belgium, Switzerland, the Netherlands, and France. Top applicants include pharmaceutical, biotech companies, and research centres, like Novartis, GlaxoSmithKline, Merck, Crucell, and Temasek Life.

The TWN study lists a series of examples of patent applications, such as Baxter International, for the production of influenza vaccines, published in July 2010. This patent application includes animal and human H5N1 types from China, Vietnam, Indonesia, Thailand, Cambodia, Turkey, and Singapore.

According to the study, developing countries “collect and share influenza viruses with WHO’s Global Influenza Surveillance Network with the understanding that those viruses are to be used for public health.” However, proprietary claims can prevent access to technology and products produced with a given technology, the study said.

A patent application from Novartis, published on 2 March 2011, claims reverse genetics systems. A reverse genetics system allows a lab to synthesise viruses with their genetic code and produce them in cell culture, enabling a faster production of vaccines, as described in the patent application. Access to reverse genetics technology is important for developing countries, the study said, as it can enable them to create their own vaccine strains.

According to the TWN study, WIPO’s approach was too narrow and its patent search and categorisation methods diminished the usefulness of its study, limited and miscategorised its results.

In particular, there are two main concerns, Hammond told Intellectual Property Watch. One is the scope of the WIPO study, which limited the search to genetic material. According to the TWN study, “claims on a variety of other related subject matter, such as influenza vaccine adjuvants, influenza reverse genetics systems, and influenza cell culture have direct bearing on governmental preparedness efforts.” These types of patent were “expressly excluded from the WIPO report and do not figure within its results.” WIPO and WHO “determined” to limit the search to “patents or patent applications claiming inventions comprising the virus, a component, or a derivative of the virus, for diagnostic, therapeutic, or prophylactic purposes.”

Some important influenza vaccine technologies were thus ignored, Hammond said.

The other concern is WIPO’s methodology, Hammond said, with weaknesses in the methodology that led to an undercount of relevant intellectual property claims. “Ironically, the WIPO report does not significantly rely on WIPO’s own system for categorising patents by subject matter – the International Patent Classification (IPC) system,” the TWN report said, adding that the IPC categories contain a specific classification for influenza vaccines, for example.

According to Hammond, the WIPO report fuels the concerns of civil society about the increasing intellectual property claims on influenza materials and shows a large amount of IP.

“There are many reasons to expect that if WIPO adopted a more appropriate search scope and methods less prone to omissions … WIPO’s results would include even more patent applications on influenza genetic resources and their use that could prove problematic for developing countries in the event of a pandemic – and highly profitable for the companies and others that claim exclusive rights to them,” the TWN concluded.

The WIPO study said that new intellectual property management models are emerging that facilitate broad access to new technologies by developing countries, including open innovation, growing investments in developing countries and increased ability of developing countries to undertake health innovation, industry’s growing willingness to work proactively to increase developing country licensing. The study also found that developing countries are increasingly using IP as a tool for development, and “patents are vehicles for disclosing inventions and for making technologies publicly known.”

Comments

Lack of influenza preparedness is the subprime crisis of the health sector. When WHO was rightly accused by Indonesia of passing on biological diversity (flu virus specimens) to its collaborating centre “partners” for commercial purposes in violation of its own guidelines, it simply removed the guidelines from its website. Were corrective measures taken in the face of a “pandemic” or was any action taken to comply with the Convention on Biological Diversity? No. And for WHO and WIPO to decide to limit the study into patents shows the obsequiousness of WHO to vested interests because when productivity really counts in a pandemic, these productivity techniques are protected intellectual property of the ‘trade secret’ know-how type. It matters little that well into the “pandemic” only 2 developing countries were in readiness to receive the vaccines. When it comes to money and managing conflicts of interest and rewarding ineptness, WHO does not fail, once again. Now if only the same scrutiny were given to developing country biodiversity in relation to HIV resistance, we may have another fight…